Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

NCT00632333 | Unknown Phase 1 DMC

• 1 other identifier: TPR07-079
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Conditions

Esophageal Cancer

Keywords

Epitope peptide; Vaccination; Chemoradiation; Esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Safety(toxicities as assessed by NCI CTCAE version3)

  3 months

Secondary Outcomes (6)

• Peptide specific CTL induction

  3 months

• DTH to peptide

  3 months

• Changes in levels of regulatory T cells

  3 months

• Objective response rate as assessed by RECIST criteria

  1 year

• Time to progression

  1 year

Study Arms (1)

1

EXPERIMENTAL

Biological: URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil

Interventions

URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil BIOLOGICAL

Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.

Also known as: CDDP, 5-FU

1

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
• measurable disease by CT scan
• ECOG performance status of 0 to 2
• Expected survival of at lease 3months
• Patients must be HLA-A2402
• Laboratory values as follow:
• WBC \> 2000/mm3,
• Platelet count \> 75000/mm3,
• Total bilirubin \< 1.5 x the institutional normal upper limits,
• Creatinine \< 1.5 x the institutional normal upper limits,
• AST. ALT. ALP \< 2.5 x the institutional normal upper limits
• Able and willing to give valid written informed consent

You may not qualify if:

• Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
• Breastfeeding
• Active or uncontrolled infection
• Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
• Concurrent treatment with steroid or immunosuppressing agent
• Patient with peptic ulcer disease
• Active or uncontrolled other malignancy
• Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
• Disease to the central nervous system
• Decision of unsuitableness by principal investigator or physician-in-charge

Sponsors & Collaborators

• Teikyo University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

Teikyo University

2-11-1 Kaga Itabashi-ku, Tokyo, 173-0003, Japan

RECRUITING

Related Publications (13)

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  PMID: 12070285 BACKGROUND

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  PMID: 16002679 BACKGROUND

• Nakopoulou L, Stefanaki K, Panayotopoulou E, Giannopoulou I, Athanassiadou P, Gakiopoulou-Givalou H, Louvrou A. Expression of the vascular endothelial growth factor receptor-2/Flk-1 in breast carcinomas: correlation with proliferation. Hum Pathol. 2002 Sep;33(9):863-70. doi: 10.1053/hupa.2002.126879.

  PMID: 12378509 BACKGROUND

• Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.

  PMID: 16630140 BACKGROUND

• Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x.

  PMID: 16108831 BACKGROUND

• Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321.

  PMID: 9500606 BACKGROUND

• Ishida K, Ando N, Yamamoto S, Ide H, Shinoda M. Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516). Jpn J Clin Oncol. 2004 Oct;34(10):615-9. doi: 10.1093/jjco/hyh107.

  PMID: 15591460 BACKGROUND

• Waters JS, Tait D, Cunningham D, Padhani AR, Hill ME, Falk S, Lofts F, Norman A, Oates J, Hill A. A multicentre phase II trial of primary chemotherapy with cisplatin and protracted venous infusion 5-fluorouracil followed by chemoradiation in patients with carcinoma of the oesophagus. Ann Oncol. 2002 Nov;13(11):1763-70. doi: 10.1093/annonc/mdf301.

  PMID: 12419749 BACKGROUND

• Marchand M, van Baren N, Weynants P, Brichard V, Dreno B, Tessier MH, Rankin E, Parmiani G, Arienti F, Humblet Y, Bourlond A, Vanwijck R, Lienard D, Beauduin M, Dietrich PY, Russo V, Kerger J, Masucci G, Jager E, De Greve J, Atzpodien J, Brasseur F, Coulie PG, van der Bruggen P, Boon T. Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer. 1999 Jan 18;80(2):219-30. doi: 10.1002/(sici)1097-0215(19990118)80:23.0.co;2-s.

  PMID: 9935203 BACKGROUND

• Iinuma H, Fukushima R, Inaba T, Tamura J, Inoue T, Ogawa E, Horikawa M, Ikeda Y, Matsutani N, Takeda K, Yoshida K, Tsunoda T, Ikeda T, Nakamura Y, Okinaga K. Phase I clinical study of multiple epitope peptide vaccine combined with chemoradiation therapy in esophageal cancer patients. J Transl Med. 2014 Apr 3;12:84. doi: 10.1186/1479-5876-12-84.

  PMID: 24708624 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

LY6K protein, human; Receptor Protein-Tyrosine Kinases; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kota Okinaga, MD, PhD

  Teikyo University , Department Surgery

  STUDY CHAIR

Central Study Contacts

Hisae Iinuma, PhD

CONTACT

+81-33-964-1211; iinuma@med.teikyo-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 21, 2011

Record last verified: 2009-09

Locations

JP (1)